Recall Z-0814-2020 — Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
U.S. FDA — Device Enforcement · United States · 2019-11-25 · Class I
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Reported risk: GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.
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